510(k) Report

Devices descending from K173384

4 later devices reach BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes…Vitaltec Corporation20251—
+1K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy…Smiths Medical Asd, Inc.20210—
+1K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien20200—
+2K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series)…Vitaltec Corporation20260—